- Lilly (Philadelphia, PA)
- …make life better for people around the world. Responsibilities: The Associate / Manager, CMC Regulatory and IMP Manufacturing Operations is a hybrid role within ... more
- Amgen (Washington, DC)
- …a career you can be proud of. **Live** **What you will do** The Global CMC Regulatory Affairs Senior Manager is responsible for execution and/ or coordination of ... more
- Boehringer Ingelheim (Ridgefield, CT)
- …and competitive advantage lie with our people. The Associate Director, US Product CMC Regulatory Affairs is responsible for the coordination and execution of ... more
- Takeda Pharmaceuticals (Boston, MA)
- …the following job opportunity: **JOB LOCATION:** Cambridge, MA **POSITION** : Manager, CMC Regulatory Compliance (GRA, CMC ) **POSITION DESCRIPTION:** Takeda ... more
- Regeneron Pharmaceuticals (Troy, NY)
- …including, but not limited to monoclonal antibodies and bioconjugates. As a Senior CMC Regulatory Sciences Specialist, a typical day might include the following: ... more
- Lilly (Philadelphia, PA)
- …support communities through philanthropy and volunteerism. **Position Overview:** The Manager - CMC Regulatory is responsible for the preparation and delivery of ... more
- US Tech Solutions (North Chicago, IL)
- …Degree:** Chemistry/ Biology/ Pharmacy/ Engineering/ Other Related Subject 2. **2-4 years CMC Regulatory experience** - Remote, in person preferred **Preferred ... more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …portfolios assigned. **A typical day may include the following:** + Responsible for CMC product development activities from a regulatory standpoint during early ... more
- Amgen (New Albany, OH)
- … Site Team is responsible for input to the development and implementation of CMC regulatory strategies and activities for products manufactured at or planned for ... more
- Lilly (Indianapolis, IN)
- …manages the scientific and regulatory efforts of the team, overseeing CMC regulatory activities for global submissions and interactions with regulatory ... more
- Lilly (Indianapolis, IN)
- … CMC technical knowledge and regulatory science expertise to drive regulatory CMC strategies and develop submissions for marketing authorizations for the ... more
- Gilead Sciences, Inc. (Foster City, CA)
- … candidate to sit at our Foster City, CA site. **Responsibilities:** + The CMC Regulatory Affairs Associate Director at Gilead is responsible for providing ... more
- Organon & Co. (Jersey City, NJ)
- … strategies. Prepare and review of information required for development of Regulatory CMC dossiers for projects and products including clinical development, ... more
- BeiGene (Harrisburg, PA)
- …seeking an experienced and instrumental regulatory professional to lead US biologics regulatory CMC team. This individual leads biologics regulatory ... more
- Takeda Pharmaceuticals (Boston, MA)
- …knowledge. **Job Description** **OBJECTIVE / PURPOSE** + Providesprogram leadership and develops CMC regulatory strategy in support of global vaccine programs in ... more
- Amgen (Washington, DC)
- …management. Key Responsibilities Include: + Generate and execute of global and country-specific regulatory strategies + Provide CMC regulatory strategy for ... more
- Eurofins (Indianapolis, IN)
- … development strategies and submission content. + Makes technical decisions on CMC regulatory issues impacting product submissions across geographies, with ... more
- Boehringer Ingelheim (Ridgefield, CT)
- …supplemented by internal BI capabilities. + Oversee the preparation and submission of CMC regulatory documents, including INDs, NDAs, and BLAs. + Collaborate ... more
- AbbVie (North Chicago, IL)
- …Chemistry, Manufacturing, and Controls ( CMC ) strategic project plans to support CMC regulatory deliverables such as INDs/IMPDs and Marketing Applications. ... more
- Vera Therapeutics (Brisbane, CA)
- …Development in project teams. * Prepare, review, or edit cGMP batch records, CMC regulatory and quality documents. Qualifications: * PhD/MS in relevant life ... more